The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a real-world setting

• Published in: Hepatology international Vol. 13; no. 2; pp. 199 - 204
• Main Authors: Obi, Shuntaro, Sato, Takahisa, Sato, Shinpei, Kanda, Miho, Tokudome, Yuta, Kojima, Yuichiro, Suzuki, Yoji, Hosoda, Kenji, Kawai, Toshihiro, Kondo, Yuji, Isomura, Yoshihiro, Ohyama, Hiroshi, Nakagomi, Keiko, Ashizawa, Hiroshi, Miura, Yuko, Amano, Hiroyuki, Mochizuki, Hitoshi, Omata, Masao
• Format: Journal Article
• Language: English
• Published: New Delhi Springer India 12.03.2019; Springer Nature B.V
• Subjects: Adverse events; Body weight; Colorectal Surgery; Criteria; Evaluation; Fatigue; Growth factors; Hepatocellular carcinoma; Hepatology; Hypertension; Liver cancer; Medical treatment; Medicine; Medicine & Public Health; Original Article; Patients; Proteinuria; Receptors; Safety; Solid tumors; Stem cell factor; Stem cells; Surgery; Toxicity; Transfection; Tumors; Vascular endothelial growth factor; Hepatocellular carcinoma; Efficacy; Lenvatinib; Clinical practice
• ISSN: 1936-0533; 1936-0541
• DOI: 10.1007/s12072-019-09929-4

Background/purpose Lenvatinib (an inhibitor of vascular endothelial growth factor (GF) receptors 1–3, fibroblast GF receptors 1–4, platelet-derived GF receptor α, rearranged during transfection, and stem cell factor receptor) was non-inferior to sorafenib in a phase 3 (REFLECT) trial of advanced hepatocellular carcinoma. This study examined the efficacy and safety of lenvatinib in a real-world setting. Methods This was a retrospective, multicenter, observational study. Inclusion and exclusion criteria were based on the phase 3 trial, and participants were observed for at least 12 weeks. Therapeutic effect was determined using the modified Response Evaluation Criteria In Solid Tumors (m-RECIST) at the 8th week. Patients received oral lenvatinib 12 mg/day (body weight > 60 kg) or 8 mg/day (body weight < 60 kg). Dose interruptions followed by reductions for lenvatinib-related toxicities were permitted. Grades of adverse events (AEs) complied with the Common Terminology Criteria for Adverse Events version 4.0. Results All 16 patients included in this study had prior treatment history, and a median 3.9 years had passed since the first treatment. Fatigue, hypertension, and proteinuria were the most frequent AEs, and were higher than Grade 2. AEs could be controlled by appropriate dose reduction, interruption, and symptomatic treatment according to the protocol. In the m-RECIST evaluation at the 8th week, 0, 6, 8, and 1 patients had achieved complete response, partial response, stable disease, and progressive disease, respectively. The objective response rate was 40%. Conclusion Lenvatinib treatment could be accomplished with safety and good response in a real-world setting.